JP2002525169A - Heart valve with tissue and outer sheath secured by anchor - Google Patents

Abstract

(57) Abstract: An apparatus and method for constructing a heart valve prepared by autologous tissue. The three pieces of tissue are held in place by tissue anchors in a tissue mounting frame having an annular base and a plurality of commissure posts extending from the base. The elastomeric sheath rests loosely on the piece so that the piece does not come off the fixation hook and surrounds the piece to form a leaflet. The pieces are in contact with each other at a joint line having an angle of about 65 ° to the commissure posts. Heart valves can be surgically constructed in a short time, typically 10 minutes. Narrow joint angles and the fact that the pieces are held in place without being clamped between the two inflexible members minimize the force on the tissue.

Description

DETAILED DESCRIPTION OF THE INVENTION

TECHNICAL FIELD The present invention relates to an improvement in a heart valve using autologous tissue held in place by an anchor and an outer sheath. Heart valves can be surgically constructed in a short time, typically within 10 minutes.

BACKGROUND OF THE INVENTION [0002] Various types of heart valves are currently available for use in place of diseased or dysfunctional human heart valves.

One type of heart valve is composed of animal tissue, typically of bovine or porcine arterial valve tissue. These valves must typically be constructed in a laboratory and stored in an aldehyde solution with sufficient time allowance before needed. A technician of this skill needs to assemble these valves. Valves composed of animal tissue have a relatively short life. Short life is due to two factors. First, the body undergoes an antigenic reaction against animal tissue that causes calcification of the tissue, resulting in the tissue becoming less flexible and more sensitive over time, resulting in dysfunction. Second, the tissue is used to reduce the antigen response
It is often stored in glutaraldehyde before transplantation,
The tissue becomes skin-like and durable, but wears out due to strain caused by repeated opening and closing.

[0003] Thus, while such animal tissue flaps are widely used, they must be replaced after about 5 to 10 years. Valve replacement requires a second heart-opening procedure, which entails potential problems during the procedure, creating a dangerous situation for the patient.

[0004] Mechanical heart valves are also available. The valve is formed from a rigid non-living material such as metal or ceramic. Although mechanical heart valves are durable, blood clots tend to form on the rigid non-living material side of the valve. Blood clots can cause a heart attack or heart attack, so that patients with mechanical heart valves must take anticoagulants. Such drugs can cause complications with bleeding. In addition, patients taking such drugs must undergo frequent and prolonged tests for blood clotting times.

[0005] Other types of heart valves, biological tissue valves, are comprised of the patient's own tissue. Many patents on autologous heart valves and methods of forming autologous heart valves, such as U.S. Patent Nos. 5,161,955 and 5,326,371,
It has been issued to Autogenics, the assignee of the present application.

SUMMARY OF THE INVENTION The present invention provides improved devices and methods for forming autologous heart valves. An important element of the present invention is that by forming the autologous tissue and the means for attaching the valve to the frame, no harmful forces can be applied to the tissue.

[0007] By forming pericardial tissue excised from the patient into three separate semi-circular pieces of tissue having a plurality of tissue fixation holes arranged along the tissue leaflet line, Self-organization can be accurately arranged. The locations of these tissue fixation holes correspond to tissue fixation hooks permanently attached to the tissue mounting frame.

[0008] The three pieces of tissue are arranged continuously on the tissue fixing hook of the tissue mounting frame so as to completely surround the periphery of the tissue mounting frame. The elastomeric sheath is stretched outside the tissue mounting frame. The sheath prevents the tissue from coming off the tissue fixation hook and rests loosely on the tissue around the leaflet line so that the tissue forms a natural closure valve.

An important feature of the present invention is that the autologous tissue is supported such that a reduction in the force on the tissue is not impeded. For example, the tissue engages the outer perimeter of the tissue piece between the elastomeric sheath member and the inner tissue mounting frame, without being clamped between the two inflexible members, between the anchor that is aligned with the tissue anchoring hole. Supported and retained by combining with an elastomeric sheath.

[0010] Another feature of the present invention is that the piece of tissue is shaped to provide sufficient extra tissue area, thereby providing a physiologically similar joint angle, thus providing a sheath. Thus, the extension of the tissue held at the predetermined position is reduced, and accordingly, the force applied to the tissue is further reduced.

Preferred Embodiment FIG. 1 illustrates a heart valve 9 composed of autologous tissue assembled according to the present invention. The valve is assembled from several factory-manufactured components during the surgical procedure, using the patient's own tissue. Referring to FIGS. 3C and 7A, these components include a tissue mounting frame 40 (FIG. 3) having a plurality of tissue fixation hooks 34 and 36.
C) is included. The tissue mounting frame 40 includes three separate autologous tissue pieces 50 (
One of them is shown in FIG. 7A). The three piece final assembly 90 is shown in FIG. The elastomeric outer sheath 42 covers the tissue mounting frame and helps to hold the tissue in place on the frame without undue force on the tissue pieces.
An annular suture ring 70 is mounted to the base of the tissue mounting frame and elastomeric sheath and is used in a conventional manner to hold the assembled valve 9 in place within the patient's heart. As described below, the valve is designed to be surgically assembled by the surgeon during the procedure to open the heart. Typical assembly times are on the order of 10 minutes. The components of the tissue mounting frame 40 tissue mounting frame 40, 2A, 2B, 3A, 3B, 3
C, FIG. 3D, FIG. 4 and FIG. FIG. 2A illustrates the inner frame 10.
The inner frame 10 is preferably manufactured with a base having three commissure posts 14 extending from the base 12. In the assembled valve illustrated in FIG.
These commissure posts 14 are located along the blood flow axis in the valve. 3
When the inner frame is assembled, the three commissure posts 14
Preferably, they are equally spaced along the inner frame so as to split at an angle of 20 °. The post is preferably continuous with the scalloped wall 16 and the end 18 of the inner frame is preferably inclined at an angle rather than perpendicular to the base 12. A plurality of inner frame holes 20 are arranged along the circumference of the scalloped wall 16 and the commissure posts 14.

The inner frame 10 can be formed from a variety of materials suitable for use in vivo, such as certain metals and plastics. As a forming material, metal is generally preferable to plastic, and Elgiloy is particularly preferable for forming the inner frame 10. A particularly preferred plastic is delrin.

FIG. 2B illustrates the outer frame 24 of the tissue mounting frame 40. The outer frame, like the inner frame, is configured with a base 12a having a plurality of commissure posts 14a continuous by scalloped walls 16a. Furthermore, the end 1 of the outer frame
8a is preferably inclined. A plurality of outer frame holes 26 are arranged along a leaf leaf line 30 indicated by a dotted line in FIG. 2B. The leaflet line 30 is disposed close to the circumference of the scalloped wall 16a and the commissure post 14a. The number of inner frame holes and outer frame holes varies depending on the size of the valve, but is generally 21 to 24. As described below, the outer frame holes are formed so as to be juxtaposed with the corresponding inner frame holes when the inner frame and the outer frame are assembled. In addition, the outer frame can be formed from various materials such as certain metals and prestics. Elgiloy is particularly preferred.

The approximate location of the weld area 32 is shown by hatching in FIG. 2B. This welding area is generally an area on the inner surface of the outer frame 24 that is later welded to the outer surface of the inner frame 10 so that the two inner frames 10 and the outer frame 24 are permanently bonded.

The inner frame 10 and the outer frame 24 are rounded so that their outer shapes are cylindrical. Although the outer frame 24 is shown alone in FIG. 3A, the outer shapes of the two cylindrical members are very similar. Next, the two members 10 and 24 are positioned concentrically with each other and spot welded in a weld region 32 proximate the base 12 to form the structure shown in FIG. 3B. Frame ends 18 and 18a are spaced 120 ° apart when the two frames are welded.

The commissure post anchors 34 (FIG. 4) and the leaflet anchors 36 (FIG. 5) are manufactured from metal, preferably Elgiloy. This anchor 34 is a hook portion 34a
And the anchor 36 includes a protrusion 36a, the hook 34a and the protrusion 3a.
6a is used to permanently attach the anchor to the tissue mounting frame 40. Hooks are inserted from the inside of the inner and outer frames, which are cylindrical and connected via the inner and outer frame holes 20 and 26, to engage the hooks (as shown in FIGS. 3C and 3B). It extends outside the outer frame surface. The protrusion 36 is located on the inner frame 10 and is spot welded to the inner surface of the outer frame 24 through the corresponding inner frame hole 20. As best shown in FIG. 6, the protrusion 34a is adjacent to the inner surface of the outer frame 24 and is located within a larger corresponding inner frame hole 20. As will become apparent below, FIG.
And as shown in FIG. 5, the anchor 34 of the commissure post is slightly longer than the leaflet anchor 36 to hold two layers of tissue rather than one layer for the leaflet anchor.

FIG. 3D is a more detailed view of the commissure post anchor 34 that extends through the outer frame hole 26 in the outer frame 24. The projection of the commissure post anchor 34 passes through a larger inner frame hole 20 (not shown) in the inner frame 10 and is spot welded to the inner wall of the outer frame 24.

As shown in FIGS. 3C, 3D, and 6, the hook portion of the commissure post anchor 34 faces upward, but in FIG. 3C, the hook portion of the leaflet line anchor 36 separates from the leaflet line 30. Is shown facing down. 2 for each commissure post 14
Typically, but not necessarily, a book commissure post anchor 34 is provided.

The tissue mounting frame 40 is manufactured in various sizes to suit the needs of each individual patient after the surgeon removes the patient's valves during the open heart surgery. Typical sizes currently used are 19, 21, 23, and 25 mm valves. The number of leaflet anchors varies depending on the size of the tissue mounting frame. 6 commissure post anchors (2 per post) and 15 per valve
It is common to have ~ 18 leaflet anchors.

FIG. 6 is a cross-sectional view from one side of the assembled tissue mounting frame 40 showing the inner frame 10, outer frame 24, and commissure post anchors 34. The two commissure post anchors 34 pass through the inner frame hole 20 and are welded to the inner wall of the outer frame 24. Although not shown, the leaflet line anchor 34 is similarly connected to the frame 4.
0 is welded to the lower part.

After the inner frame 10, the outer frame 24, the commissure post anchors 34, and the leaflet anchors 36 are welded and assembled, the assembled tissue mounting frame 40 is covered on both sides with Dacron cloth 38 (FIG. 11B). Dacron
It is a registered trademark of DuPont for polyethylene terephthalate.

Since it is difficult to illustrate this cloth in the drawings, FIG.
11B and 11C show the Dacron cloth 38 as a broken line 38 on the mounting frame 40, similar to the sheath 42 and the suturing ring 70 (described below). Commissural post anchors 34 and leaflet anchors 36 extend through the Dacron. As noted above, the spot welded anchor is substantially planar, but only slightly (typically 0.003 inches) protruding from the inner surface of the inner frame. As a result, when the frame is covered with Dacron, the inner surface is flat, except for the Dacron coupling surface. By covering the frame with Dacron, non-living materials such as the metal of the frame are isolated from the body. In addition, the goal of promoting tissue inward from the interstices of the fabric to isolate the non-biomaterial from the body and integrate the valve into the heart is achieved. This helps to avoid the problem of thromboembolism. In addition, this provides a gradual interaction area between the metal and plastic components of the valve and the tissue, allowing blood to flow freely to the tissue, thereby fostering the tissue and increasing its viability. .

While a Dacron cover for a frame can be prepared in various ways, one advantageous method is described in US Pat. No. 5,163,955, which is incorporated herein by reference. Shall be incorporated in A three finger Dacron sock or glove is shown and described in FIG. 4A of the patent. Three-finger socks are formed by heat seaming the Dacron portion using any of the hot wire, hot soldering, or ultrasonic techniques. Alternatively, the entire glove can be woven or knitted as one piece. The glove is then turned upside down (to release the suture from the bloodstream) and pulled in the tissue frame and secured at the base of the glove by heat seaming. Similar manufacturing methods can be used for the other Dacron covers described herein. Self-Tissue Piece The self-tissue piece 50 is substantially semicircular as shown in FIG. 7A. Details such as the method of forming this piece will be described below. As shown by the dotted line in FIG. 7A, the tissue piece 50 has a plurality of tissue fixing holes 58 disposed along the tissue leaflet line 62. The bevel 66 of the tissue piece is preferably cut off at one corner to ensure that the piece is placed partially overlying the previous piece. While forming the valve surgically, the tissue pieces are fitted into the assembled commissure post anchors 34 and leaflet anchors 36 by these tissue holes 58 to be accurately positioned relative to the tissue frame. You. FIG. 8 shows a state in which the tissue piece 50 is attached to the commissure post anchor.
Illustrated in FIG. As shown, the partially overlapping tissue pieces 50a and 50b are mounted on the tissue mounting frame 40 by being inserted into the tissue fixing holes 58 and into the hooks of the anchors 34 of the commissure posts. As a result, two layers of tissue pieces 50 are attached to anchors 34 of each commissure post. However, only one piece exists in the lower part of the frame where the tissue pieces do not overlap. The leaflet anchor 36 (not shown in FIG. 8) has a hook that does not extend significantly out of the frame 40. Elastomer Sheath Elastomer sheath 42 is illustrated in FIG. 9A. The elastomer sheath has a shape substantially similar to the shape of the tissue mounting frame 40, and includes an annular elastomer sheath base 44 and three elastomer sheath commissure posts 46 extending from the base. The elastomeric sheath commissure post 46 is continuous with the elastomeric sheath scalloped wall 48. The positions and numbers of the plurality of elastomeric sheath holes 64 match the positions and numbers of the commissure post anchors 34 and the leaflet line anchors 36 of the frame 40. The elastomer sheath 42 is preferably formed from silicone rubber covered on both sides with a Dacron cloth.

The elastomeric sheath 42 is further provided in FIGS. 9A, 10A, 10B, and 10C.
, FIG. 11A and FIG. 11B. 10A, 10B, and 10C are:
It should be noted that the sheath is shown in these figures as being attached to the frame 40 without the self-piece 50, but for illustration purposes only. Such a condition does not occur during the formation of the valve because the pieces are first attached to the tissue attachment frame 40 by the tissue anchors 34, 36, and only then are the sheath 42 moved into position. The cross section of the elastomeric sheath 42, best illustrated in FIG. 9B, appears to be an inverted "J" with two edges adjacent to the elastomeric sheath base 44. The elastomeric sheath 42 is designed to be tensioned to a frame structure assembled with three pieces mounted. As best shown in FIG. 11B, the elastomeric sheath 4
2, when pulled into the assembled frame structure, the tissue anchors 34 and 36 are loosely positioned within the elastomer sheath holes 50 covered by Dacron.

The upper surface of the inverted “J” shaped outer elastomeric sheath matches the upper surface of the commissure posts 14 of the frame 40. The tissue piece 50 is mounted on the commissure post anchor 34 and the leaflet line hook 36 and then held in place between the inner wall of the elastomeric sheath 42 and the tissue mounting frame 40. Elastomer sheath holes 64 receive the hooks of commissure post anchors 34 and leaflet anchors 36 that protrude from the tissue. FIG. 10A illustrates commissure post anchors 34 and leaflet anchors 36 fitted in elastomeric sheath holes 64.

The elastomer sheath 42 is secured to the base by the Dacron cover by heat welding, stitching, and stitching to the Dacron cover of the frame assembly. Elastomeric sheath 42 is further an elastomer sheath pocket 84 disposed on the top of the inverted "J" shaped external sheath ((FIG. 11B),. Sewing rings view held in place commissural posts 14 of the frame 11A, 11B, 11C, 12A and 12B, a dacron-covered suture ring 70 is located at the base of the assembled valve, the cross-section of which is advantageously wedge-shaped. Although other materials can be used, it is preferably formed of flexible, elastic and durable silicone rubber.
The suture ring is thin and flexible so that when the valve is implanted in the patient, the suture ring exactly conforms to the scallop of the aortic root.

As shown in FIGS. 11B and 11C, the suturing ring, the tissue mounting frame, and the elastomeric sheath are connected by joining all six layers of Dacron together at the heat weld point 110. The heated weld point 110 is formed by the suturing ring substantially aligned with the tissue mounting frame. When the suture ring is moved to the position shown in FIG. 11B, the weld point is hidden between the suture ring and the outer sheath. This prevents thromboembolism from occurring on the relatively smooth weld surface.

The tissue mounting frame, tissue anchor, and elastomeric sheath are kits that can be pre-assembled and shipped at the factory for use in the operating room. The kit can be assembled at the factory and the elastomeric sheath can be aligned with the tissue mounting frame. As described above, the elastomer sheath of the tissue mounting frame is covered with Dacron, and the layer of Dacron is
Preferably, welding is performed by a heat welding point 110 shown in FIG.

If desired, the kit may further include a suture ring mounted on the elastomeric sheath of the tissue mounting frame. As described above, the suture ring is also preferably covered by Dacron and attached to the elastomeric sheath of the tissue mounting frame by welding the six Dacron layers at the heat weld point 110. Preparation of Autologous Tissue Piece 50 The general shape of each tissue piece 50 is illustrated in FIG. 7A. This shape is designed to be a leaflet shape and to minimize the force on the tissue. As shown in FIG. 2B, the length of the tissue along the tissue leaflet line 94 is slightly longer than the leaflet line length 30 of the tissue frame. As a result, the excess tissue can form a ridge that is not significantly different from the cup shape, ie, the shape used to form the chest of the women's clothing. There is more tissue than is required for leaflet length, but not enough to cause folds or wrinkles in the tissue.

[0030] The tissue piece is typically cut by a tissue cutting die, adapted to the size of the final valve and further adapted to provide more tissue on one side of the piece. Examples of cutting dies suitable for cutting autologous tissue into a predetermined shape are shown and described in U.S. Patent Nos. 5,163,955 and 5,425,741. In a preferred embodiment, the disposable tissue cutting die comprises:
It will be used and will be used in housings that may not be disposable.

As shown in FIG. 11B, the cutting die is used to cut the tissue piece 50 to account for the extra tissue needed to cover on the commissure posts 14 for use in the present invention. It is configured as follows. The adjacent piece at the commissure post (
In the portion of the piece of tissue located above the piece 50a) of FIG. 11B, the radius along the joint line of the piece of tissue has been increased by the length necessary to cover the inner piece of tissue.
A tissue cutting die or other cutting device was used to provide such extra tissue on one side of the tissue piece and cut the piece over the previously placed piece to see where to place the piece. It is configured to chamfer one corner of the piece. The bevel 66 of the tissue piece is illustrated in FIG. 7A.

A longer end of the top piece of tissue is illustrated in FIG. 10C. The radius along the joining line of the tissue piece located on the adjacent tissue piece (piece 50a in FIG. 11B) is extra long by the length needed to cover the inner tissue piece. The extra tissue measured from the center line of the piece of tissue is shown as hatched area 98 in FIG. 7B.

In addition to the tissue cutting die, other surgical techniques can be used to cut tissue pieces accurately, such as a water jet or laser cutting device.

A feature of a preferred embodiment of the present invention is that no horizontal joint lines are required. FIG.
As shown in FIG. 3, such a horizontal joint line 104 greatly increases the force on the tissue at the commissure post 14. This is similar to the tension required to keep a laundry line very taut when compared to a line that is allowed to have some curvature. In a heart valve constructed according to a preferred embodiment of the present invention, the outer elastomeric sheath 42 is
The tissue pieces 50a and 50b near the commissure post 14 are held. The length of the tissue along the joint line is at least twice the radius of the valve. Taking into account the elongation of the tissue, this extra tissue results in an angle of the mating surface relative to the commissure post angle of about 65 °, 102 in FIG. As described above, the joint angle θ is reduced, so that the commissure post 1
The force on the piece of tissue at 4 is greatly reduced.

The tissue for forming the tissue piece 50 is preferably an autologous tissue such as a pericardial tissue, but may be a femoral fascia tissue, a rectus fascia tissue, or a vein tissue. All of these tissue sources are relatively brittle and difficult to handle. The reason is that the thickness of the tissue once removed is about 10 to 12 mils. By comparison, bovine pericardial thickness is about 15 to 20 mils. Tissues are typically 0.625% after removal
Partially cure for about 10 minutes by soaking in a glutaraldehyde solution. This makes the tissue more robust and easier to handle.

[0036] Other sources of tissue that can replace autologous tissue can be bovine pericardial tissue or other xenograft tissue. Further, it can be an allograft tissue. These tissues can be pre-cut by the annuloplasty or valve manufacturer outside the operating room and stored by conventional methods. However, when using other tissue sources, the dimensions of the components are adjusted to accommodate the tissue, but are generally thicker than the preferred tissue source. Irrigation, extraction, and curing processes for surgical valve formation autologous tissue are known and are described, for example, in US Pat. No. 5,163,955.

As described above, following curing, the piece 50 is cut into three pieces.

The three pieces have a cutout angle 66 (FIG. 7A), are sized to partially overlap, and are placed on top of the previously placed piece. These pieces are placed successively on the tissue fixation hooks 34 and 36 in a tissue mounting frame 40 covered with cloth.

Next, the elastomeric sheath 42 is positioned such that the concave pocket 84 disposed on each of the elastomeric sheath commissure posts 46 of the elastomeric sheath 42 is keyed above the commissure posts 14 of the tissue mounting frame 40. Bent or rolled over to cover the frame 40 and the mounted piece of tissue. In a preferred embodiment,
The elastomer sheath covered with Dacron rests loosely on the tissue piece near the leaflet line (see FIG. 11C) so that the piece forms the natural closure valve shown in FIG. The sheath 42 prevents the piece of tissue 50 from disengaging from the tissue fixation hooks 34 and 36, and the sheath substantially removes the top of the commissure post 14 and the piece of tissue attached thereto, as shown in FIG. 10C. Surrounding, "I'm holding you." As a result, the adjacent pieces are in contact with each other at the joining line.

According to the teachings of the prior art, the completed valve is tested and then mounted in a holder for implantation. See, for example, U.S. Patent No. 5,163,955.

[Brief description of the drawings]

FIG. 1 is a perspective view of a preferred embodiment of an assembled autologous heart valve in a configuration according to the present invention.

FIG. 2A is a front view illustrating an inner frame portion of a tissue mounting frame during manufacturing.

FIG. 2B is a front view illustrating an outer frame portion of the tissue mounting frame during manufacturing.

FIG. 3A is a perspective view illustrating the outer frame after the frame is wound into a cylindrical shape.

FIG. 3B is a perspective view illustrating an inner frame and an outer frame connected concentrically.

FIG. 3C is a perspective view illustrating the tissue mounting frame before being covered by the finished fabric with the tissue anchor.

FIG. 3D is an enlarged perspective view of one of the commissure post anchors.

FIG. 4 is an enlarged view of a commissure tissue anchor.

FIG. 5 is an enlarged view of a leaflet tissue anchor.

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 3C.

FIG. 7A is a front view of one of the autologous tissue pieces.

FIG. 7B is a front view of the autologous tissue piece of FIG. 7A illustrating extra tissue to partially cover the tissue piece on the commissure hook.

FIG. 8 is a cross-sectional view of FIG. 6 further with two partially overlapping autologous tissue pieces.

FIG. 9A is a perspective view of an elastomeric sheath.

FIG. 9B is a sectional view taken along line 9B-9B in FIG. 9A.

FIG. 10A is a perspective view of an elastomeric sheath attached to a tissue mounting frame.

FIG. 10B is a front view of the elastomeric sheath shown in FIG. 10A.

FIG. 10C is a sectional view taken along line 10C-10C in FIG. 1;

11A is a sectional view taken along the line 11A-11A in FIG. 1;

11B is a sectional view taken along the line 11B-11B in FIG.

11C is a sectional view taken along the line 11C-11C in FIG.

FIG. 12A is a perspective view of a tubular suture ring before being covered with a cloth.

FIG. 12B is a sectional view taken along line 12B-12B in FIG. 12A.

FIG. 13 illustrates a reduced joint angle θ in a preferred embodiment of the present invention.

[Procedure amendment]

[Submission date] May 7, 2001 (2001.5.7)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0016

[Correction method] Change

[Correction contents]

The commissure post anchors 34 (FIG. 4) and the leaflet anchors 36 (FIG. 5) are manufactured from metal, preferably Elgiloy. This anchor 34 is a hook portion 34a
And the anchor 36 includes a protrusion 36a, the hook 34a and the protrusion 3a.
6a is used to permanently attach the anchor to the tissue mounting frame 40. Hooks are inserted from the inside of the inner and outer frames, which are cylindrical and connected via the inner and outer frame holes 20 and 26, to engage the hooks (as shown in FIGS. 3C and 3B). It extends outside the outer frame surface. The protrusion 36 a is disposed on the inner frame 10 and is spot-welded to the inner surface of the outer frame 24 through the corresponding inner frame hole 20. As best shown in FIG. 6, the protrusion 34a is adjacent to the inner surface of the outer frame 24 and is located within a larger corresponding inner frame hole 20. As will become apparent below, as shown in FIGS. 4 and 5, the commissure post anchors 34 are used to hold two layers of tissue rather than one layer for leaflet anchors. Slightly longer than anchor 36.

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0020

[Correction method] Change

[Correction contents]

FIG. 6 is a cross-sectional view from one side of the assembled tissue mounting frame 40 showing the inner frame 10, outer frame 24, and commissure post anchors 34. The two commissure post anchors 34 pass through the inner frame hole 20 and are welded to the inner wall of the outer frame 24. Although not shown, the leaflet line anchor 36 is similarly connected to the frame 4.
0 is welded to the lower part.

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] 0024

[Correction method] Change

[Correction contents]

The elastomeric sheath 42 is further provided in FIGS. 9A, 10A, 10B, and 10C.
, FIG. 11A and FIG. 11B. 10A, 10B, and 10C are:
It should be noted that the sheath is shown in these figures as being attached to the frame 40 without the self-piece 50, but for illustration purposes only. Such a condition does not occur during the formation of the valve because the pieces are first attached to the tissue attachment frame 40 by the tissue anchors 34, 36, and only then are the sheath 42 moved into position. The cross section of the elastomeric sheath 42, best illustrated in FIG. 9B, appears to be an inverted "J" with two edges adjacent to the elastomeric sheath base 44. The elastomeric sheath 42 is designed to be tensioned to a frame structure assembled with three pieces mounted. As best shown in FIG. 11B, the elastomeric sheath 4
2, when pulled into the assembled frame structure, the tissue anchors 34 and 36 are loosely positioned within the elastomer sheath holes 64 covered by Dacron.

[Procedure amendment 4]

[Document name to be amended] Drawing

[Correction target item name] FIG. 10C

[Correction method] Change

[Correction contents]

FIG. 10C

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, TZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, DE, DK, DM, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID , IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW (72) Invention Tompkins David United Kingdom Katie 12 2NA Walton-On-Thames Sidney Road 24A (72) Inventor Hemsley David United Kingdom Drewdy 3 2NN Hearts Rickmansworth Hill Rise 23 F-term (reference) 4C097 AA27 BB01 CC01 DD04 EE08

Claims (45)

[Claims] 1. A tissue mounting frame comprising: (a) a tissue mounting frame having a generally cylindrical base, three commissure posts, and a plurality of outwardly projecting tissue fixation hooks; A subassembly having a suture ring attached to the tissue mounting frame and an elastomeric sheath attached to the tissue mounting frame; and (b) three subcutaneous cuts with a plurality of mounting openings by surgery. An autologous tissue piece, wherein the tissue piece extends from one commissure post to an adjacent commissure post by being attached to each tissue fixing hook, and partially overlaps an adjacent previous piece at each commissure post. And the elastomer sheath is arranged continuously around the periphery of the tissue mounting frame in the closed state, wherein the (i) the tissue piece does not come off the tissue fixing hook. A tissue heart valve resting loosely and (ii) surrounding the commissure post and the piece of tissue attached to the post such that the piece forms a leaflet. 2. A tissue mounting valve comprising: (a) a tissue mounting frame having a generally cylindrical base, three commissure posts, and a plurality of outwardly projecting tissue fixation hooks; A suture ring attached to the tissue mounting frame, and a subassembly manufactured having an elastomeric sheath attached to the tissue mounting frame; and (b) three autologous tissue pieces cut by surgery. The tissue piece is (i) substantially semicircular, and (ii) the length of the tissue along the tissue leaflet line is slightly longer than the length of the leaflet line of the tissue mounting frame. A leaflet shape can be formed when a piece is mounted on the tissue mounting frame; and (iii) at the commissure posts of the tissue mounting frame, the tissue is partially overlapped and accommodated on adjacent pieces. Each piece (Iv) when the tissue piece is mounted on the tissue mounting frame and within the elastomeric sheath, the joining line defined by the free edges of adjacent tissue pieces is horizontal. (V) having a plurality of mounting openings, wherein the openings of the tissue pieces are separately fitted into the tissue fixing hooks, whereby the pieces are mounted on the tissue. The pieces are continuously attached around a frame, and each piece extends from the commissure post to an adjacent commissure post, and the elastomeric sheath is bent at the tissue piece so that the elastomeric sheath comprises: Loosely resting on the piece so that the piece of tissue does not come off the fixation hook; and (ii) attached to the commissure post and the commissure post A tissue heart valve wherein (i) the pieces form leaflets and (ii) adjacent pieces contact each other along the junction line by surrounding the top of the piece. 3. A tissue mounting frame comprising: (a) a tissue mounting frame having a generally cylindrical base, three commissure posts, and a plurality of outwardly projecting tissue fixation hooks; A sub-assembly having a suture ring attached to the tissue mounting frame; and (b) a plurality of pieces of tissue, wherein the pieces of tissue are surgically cut and separated. By being retained by the tissue anchor, each piece of tissue is disposed continuously around the tissue mounting frame, with each piece extending from one commissure post to an adjacent commissure post, and the elastomeric sheath is (I) resting loosely on the piece so as to maintain the piece of tissue with respect to the tissue anchor; Tissue heart valve surrounding the upper portion of the piece which is attached to the posts and said cross connecting post. 4. The tissue heart valve according to claim 3, wherein the tissue mounting frame includes an inner frame fixed to an outer frame. 5. The tissue heart valve of claim 3, wherein the piece of tissue is oversized to promote the formation of the leaflets. 6. The tissue piece is oversized so that the elastomeric sheath holds the plurality of tissue pieces with a physiologically similar joining angle of less than 90 °. A tissue heart valve according to claim 1. 7. The method of claim 6, wherein said joint angle to the commissure post is about 65 °.
A heart valve according to claim 1. 8. The heart valve according to claim 3, wherein the elastomer sheath itself adjusts so as to exert an even force on the tissue piece of the frame. 9. The heart valve of claim 3, wherein the tissue anchor is a hook and the elastomeric sheath has a plurality of holes for receiving the hook. 10. The heart valve of claim 9, wherein an opening in the elastomeric sheath accommodates an outer portion of the hook. 11. The heart valve of claim 3, wherein the elastomeric sheath is aligned with the tissue mounting frame at the factory. 12. The perimeter of the tissue piece between (i) the mounting opening of the piece separately fitted in the tissue anchor, and (ii) the outer elastomeric sheath and the inner tissue mounting frame. 4. The heart valve according to claim 3, wherein the combination of the elastomeric sheath with a mating portion supports and retains the tissue piece without clamping the tissue between two inflexible members. . 13. The tissue piece is a partially hardened autologous tissue.
A heart valve according to claim 1. 14. The heart valve according to claim 3, wherein the piece of tissue is partially hardened autologous pericardial tissue. 15. The heart valve according to claim 3, wherein the tissue mounting frame is covered with a cloth. 16. The heart valve according to claim 15, wherein the cloth is polyethylene terephthalate. 17. A soft, flexible, annular body for securing tissue to a medical device, the sheath containing the medical device and the tissue, and retaining the tissue to the medical device. Having a sheath. 18. The sheath according to claim 17, wherein the sheath has a plurality of holes in the annular body for receiving hooks in the medical device. 19. A heart valve, comprising: a frame having an annular base, a plurality of posts extending from the base, a plurality of tissue anchors attached to the frame, and a plurality of tissues held by the tissue anchor. A heart valve comprising a piece and a flexible elastomeric sheath, wherein the sheath is adapted to the frame and the piece of tissue and retains the piece of tissue at the tissue anchor. 20. The heart valve according to claim 19, wherein the elastomeric sheath comprises an annular base and a plurality of posts extending from the annular base. 21. The heart valve of claim 19, wherein the tissue anchor is a hook and the piece of tissue is retained on a plurality of hooks of the frame. 22. The heart valve according to claim 19, wherein the frame includes an inner frame and an outer frame. 23. The heart valve of claim 19, wherein the frame includes an inner frame and an outer frame connected near the base. 24. The heart valve of claim 19, wherein the piece of tissue is oversized to promote the formation of the leaflets. 25. The heart valve of claim 19, wherein the elastomeric sheath holds the plurality of pieces at a joint angle of less than 90 °. 26. The heart valve of claim 19, wherein the elastomeric sheath itself adjusts the frame to apply an equal force to the tissue piece. 27. The heart valve according to claim 21, wherein the elastomeric sheath has a plurality of holes for receiving the hooks. 28. The heart valve of claim 19, wherein the sheath is held in the post by a pocket at the frame. 29. The heart valve of claim 19, wherein the elastomeric sheath is aligned with the frame at the factory. 30. The tissue piece comprising: (i) the tissue anchor; and (ii) the elastomeric sheath engaged with the outer periphery of the tissue piece between the elastomer sheath and the frame. 20. The heart valve of claim 19, wherein the heart valve is supported and retained without clamping the tissue between the two inflexible members. 31. The tissue piece is a partially hardened autologous tissue.
10. The heart valve according to 9. 32. The heart valve according to claim 19, wherein the piece of tissue is partially hardened autologous pericardial tissue. 33. The heart valve according to claim 19, wherein the frame is covered by a cloth. 34. The heart valve according to claim 33, wherein the cloth is polyethylene terephthalate. 35. The heart valve of claim 19, further comprising a flexible annular suture ring. 36. The heart valve of claim 35, wherein the elastomeric sheath and the annular suture ring are attached to the frame. 37. The heart valve of claim 19, wherein the piece of tissue is surgically attached to the frame during a valve replacement procedure. 38. A kit for forming a heart valve, comprising: an annular base; a mounting frame having a plurality of posts extending from the base; a plurality of fixed hooks attached to the mounting frame; A flexible elastomeric sheath including a plurality of posts extending from the base, the post having a pocket in the mounting frame for retaining the sheath. 39. The kit of claim 38, further comprising a suture ring attached to said mounting frame and said elastomeric sheath. 40. The device of claim 38, wherein said mounting frame is covered by a cloth. 41. A method for assembling a heart valve, comprising cutting tissue from a patient, cutting the tissue into a piece of tissue having a plurality of holes, an annular base, a plurality of posts extending from the base, and a frame. Preparing the frame having a plurality of hooks attached to the hook, and arranging a hole of the tissue in the hook to attach the tissue piece to the frame, so that the tissue piece is formed in a heart valve leaflet. A method of assembling a heart valve, comprising bending an elastomeric sheath around a post of the frame and the piece attached to the post. 42. A method of assembling a heart valve, comprising cutting a tissue into a plurality of pieces of tissue, the frame having an annular base, a plurality of posts extending from the base, and a plurality of tissue anchors attached to the frame. A method of assembling a heart valve comprising attaching the plurality of pieces of tissue to the frame and folding an elastomeric sheath in the frame and the piece of tissue to hold the pieces in the frame. 43. A subassembly for forming a tissue heart valve, comprising: a tissue mounting frame having a generally cylindrical base, a plurality of commissure posts, and a plurality of outwardly projecting tissue anchors; A subassembly for forming a tissue heart valve, comprising: a suture ring attached to a tissue attachment frame; and an elastomeric sheath attached to the tissue attachment frame. 44. An elastomeric sheath for securing a piece of tissue to a heart valve tissue mounting frame, the sheath having an annular base and a plurality of posts extending from the base, wherein the sheath is soft and flexible. An elastomeric sheath for securing a piece of tissue to a mounting frame, the elastomeric sheath being formed from a flexible material and having a plurality of holes for receiving hooks of the mounting frame. 45. The elastomeric sheath of claim 44, wherein the cross section of the elastomeric sheath is inverted "J" shaped.